Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift Shift: (M-F | 8am to 5pm | OT may be requested based on business needs)
Description:
With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Knowledge & Requirements:
- In-depth experience of bio-processing unit operations (Cell Culture, Drug Substance Purification)
- Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe)
- Familiar with Lean Manufacturing Practices
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
- Proficiency in GDP (Good Documentation Practices) on a regulated environment
- Knowledge in systems: Trackwise, Spotfire, CDOCS, and process monitoring platforms
- Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish
Responsibilities:
- Own change controls for manufacturing process changes
- Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
- Support Risk Assessments exercises and Microbial assessment evaluations.
- Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
- Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
- Provide commercial support when needed and assist on the floor troubleshooting.
- Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.
- Assist and provide guidance during MBR (Master Batch Record) creation/revisions.
- Perform assessment to support process, automation, or equipment modification or implementation of special projects
- Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
- Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
- Complete assessments for CAPA applicability requests from other plants/sites
- Complete assessment for new or changes in BOM's (Bill of Materials)
- Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.
Education:
- Doctorate OR Master’s + 2 years of Manufacturing Operations experience OR Bachelors + 4 years of Manufacturing Operations experience OR Associates + 8 years of Manufacturing Operations experience OR High school/GED + 10 years of Manufacturing Operations experience
Skills Required
- In-depth experience of bio-processing unit operations (Cell Culture, Drug Substance Purification)
- Knowledge in Root Cause Analysis methodologies (Fishbone, 5 Why's, Kepner Tregoe, etc.)
- Familiarity with Lean Manufacturing practices
- Ability to communicate and collaborate with technical and management staff in manufacturing, process development, and quality
- Proficiency in GDP (Good Documentation Practices) in a regulated environment
- Knowledge of systems: Trackwise, Spotfire, CDOCS, and process monitoring platforms
- Strong technical writing and presentation abilities; excellent written/verbal communication skills in English and Spanish
- Education: Doctorate OR Master's + 2 years manufacturing operations OR Bachelor's + 4 years OR Associate's + 8 years OR High School/GED + 10 years
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
